A Phase 2 Study of SP-02L in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)

Central assessments of tumor response were performed by the Efficacy and Safety review Committee according to the Revised Response Criteria for Malignant Lymphoma developed in 2007 based on computed tomography (CT) and fluorodeoxyglucose-positron emission tomography (FDG-PET) findings. Overall Response Rate was defined as the percentage of participants who achieved Complete Response (CR, disappearance of all evidence of disease) or Partial Response (PR, regression of measurable disease and no new sites) as their best response. Disease Control Rate is defined as the percentage of participants who achieved CR, PR or Stable Disease (SD) as their best response.

Time frame: Central assessments of tumor response were performed every 3 cycles, and/or at the end of treatment visit, during 6-cycle treatment period. The best response was determined during 6-cycle treatment period. Maximum duration of assessments was 5.3 months.

Population: Efficacy analysis set included patients who fulfilled eligibility criteria and who took a tumor response assessment at least one time after the administration of SP-02L (darinaparsin for injection).

AE was defined as any untoward medical occurrence in a participant administered the study drug. AE included clinically significant changes in laboratory values, vital signs, and electrocardiograms. Drug-related AE was defined as AE that there was at least a reasonable possibility to have the causal relationship to the study drug. The severity of AE was evaluated by the investigator according to Common Terminology Criteria for Adverse Events (Version 4.0) where Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe or medically significant but not immediately life-threatening), Grade 4 (life-threatening consequences) and Grade 5 (death related to AE).

Time frame: From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.

Overall Survival was the duration of time from the first day of study drug administration to the date of death from any cause.

Time frame: Survival follow-up was performed for 2 years from the date of first dosing of study drug. Maximum duration was 24.9 months.

Population: Efficacy analysis set included patients who fulfilled eligibility criteria and who took a tumor response assessment at least one time after the administration of SP-02L (darinaparsin for injection).

Progression-Free Survival was the duration of time from the first day of study drug administration to the date of Progressive Disease (PD) based on local assessment or the date of death from any cause, which occurs earlier. PD was defined using the Revised Response Criteria for Malignant Lymphoma developed in 2007, as any new lesion or increase by ≥ 50% of previously involved sites from nadir.

Time frame: Tumor response was assessed at the end of every 3 cycles until documented PD. Maximum duration as of the cut-off date for data lock was 42.4 months.

Population: Efficacy analysis set included patients who fulfilled eligibility criteria and who took a tumor response assessment at least one time after the administration of SP-02L (darinaparsin for injection).

Local assessments of tumor response were performed by individual site investigators according to the Revised Response Criteria for Malignant Lymphoma developed in 2007 based on CT and FDG-PET findings. Overall Response Rate was defined as the percentage of participants who achieved CR (disappearance of all evidence of disease) or PR (regression of measurable disease and no new sites) as their best response. Disease Control Rate is defined as the percentage of participants who achieved CR, PR or SD as their best response.

Time frame: Local assessments of tumor response were performed at the end of every 3 cycles, and/or at the end of treatment visit. The best response was determined during the entire treatment period. Maximum duration of assessments was 42.4 months.

Population: Efficacy analysis set included patients who fulfilled eligibility criteria and who took a tumor response assessment at least one time after the administration of SP-02L (darinaparsin for injection).